Indole-3-PROpionic Acid Clinical Trials - a Pilot Study Part 2

NCT07105514 | Recruiting

• 1 other identifier: H-24008127 - 116180
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this trial is to investigate the biological effects of oral supplementation with indole-3-propionic acid (IPA) taken twice daily in healthy adults. The main scientific questions are:

• Does supplementation with IPA increase the abundance of regulatory T cells in the blood? Regulatory T cells are believed to play an important role in preventing autoimmune diseases.
• Does supplementation with IPA increase the concentration of brain-derived neurotrophic factor (BDNF) in the blood? BDNF is believed to play an important role in maintaining brain health.
• Does supplementation with IPA affect blood analyses commonly performed to assess the risk of metabolic disorders like type 2 diabetes and cardiovascular diseases? Participants will:
• Take capsules to achieve a total daily dose of 1000 mg of IPA or placebo: 500 mg every morning and 500 mg every evening for 14 days.
• Visit the clinic at the beginning (day 1) and at the end (day 15) of the supplementation period to deliver blood, urine and fecal samples, have simple measurements performed, fulfil questionnaires and report any side effects.

Conditions

Healthy

Keywords

indole-3-propionic acid; gut bacterial metabolite; regulatory T cells; brain-derived neurotrophic factor; dietary supplement

Outcome Measures

Primary Outcomes (2)

• Regulatory T cells (first primary outcome)

  FoxP3+CD25+CD127- regulatory T cells expressed as a percentage of single, live CD3+CD4+CD8- lymphocytes. Analysed in freshly isolated peripheral blood mononuclear cells using a Symphony A3 flowcytometer.

  Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).

• Brain-derived neurotrophic factor (second primary outcome)

  Brain-derived neurotrophic factor measured in platelet-free plasma samples using ELISA or mesoscale.

  Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).

Secondary Outcomes (30)

• Th1/Th2 ratio in PBMCs

  Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).

• Th17/mTreg ratio in PBMCs

  Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).

• Th17.1 cells in PBMCs

  Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).

• CRP

  Results from blood samples taken on day 15 (just before last supplement/placebo dose) and adjusted for results from day 1 (just before first supplement/placebo dose).

• Triglycerides

  Results from fasting blood samples taken on day 15 and adjusted for results from day 1 (fasting just before first supplement/placebo dose).

Other Outcomes (21)

• Gastrointestinal comfort

  Gastrointestinal symptoms are assessed on day 1 and day 15.

• Gastrointestinal transit time

  The maize test is performed at baseline (maize is ingested five days before visit 1) and repeated on day 10 (five days before visit 2).

• Stool consistency

  Bristol stool chart is used in association with each maize test and collection of fecal samples (earliest 48 hours prior to first visit and day 3 or soonest thereafter and again earliest 48 hours prior to last visit (day 15)).

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo

Dietary Supplement: Placebo

Indole-3-propionic acid (IPA)

EXPERIMENTAL

IPA: total daily dose of 1000 mg

Dietary Supplement: Indole-3-propionic acid (IPA)

Interventions

Indole-3-propionic acid (IPA) DIETARY_SUPPLEMENT

Two capsules are taken every morning and two capsules are taken every evening for 14 consecutive days. Active capsules are taken orally and contain 250 mg of IPA each.

Indole-3-propionic acid (IPA)

Placebo DIETARY_SUPPLEMENT

Two capsules are taken every morning and two capsules are taken every evening for 14 consecutive days. Placebo capsules are taken orally and contain maltodextrin.

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy women and men ≥18 and ≤65 years of age
• Deemed mentally and physically able to participate

You may not qualify if:

• Diagnosis of gut-, heart-, liver-, kidney or immune-related disorders
• Use of antibiotics within the last month
• Pregnancy, lactation or childbirth within the last five months
• Use of prescription medication

Sponsors & Collaborators

• Glostrup University Hospital, Copenhagen: lead
• University of Copenhagen: collaborator
• University of Southampton: collaborator

Study Sites (1)

Optic Neuritis Clinic, Danish Multiple Sclerosis Center, Department of Neurology, Copenhagen University Hospital, Rigshospitalet-Glostrup

Glostrup Municipality, 2600, Denmark

RECRUITING

Study Officials

• Jette Frederiksen, Prof, MD

  Copenhagen University Hospital, Rigshospitalet-Glostrup

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Moschoula Passali, MSc, PhD

CONTACT

+45 38633467; moschoula.passali@regionh.dk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Randomization is performed by external party. Each capsule container is labelled with a unique number (101-160) and no other identifier. Capsule containers have already been randomized by the external party using block randomization with random block sizes of 2 or 4. Study participants receive the next available capsule container based on their order of recruitment. This way, everyone involved in the study is fully blinded and it is also impossible to guess which participants belong to the same group. Only after all study participants have been recruited and the collected data have been cleaned and quality checked, are the researchers performing the statistical analyses informed about which participants belong to the same group.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof, DMSc, MD

Study Record Dates

• First Submitted: July 17, 2025
• First Posted: August 6, 2025
• Study Start: August 4, 2025
• Primary Completion: October 30, 2025
• Study Completion (Estimated): June 30, 2026
• Last Updated: August 8, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ANALYTIC CODE
• Time Frame: Beginning 3 months and ending 5 years following publication of the article they are presented in.
• Access Criteria: Researchers who provide a methodologically sound proposal can access the IPD to achieve the aims of the approved proposal. Proposals should be directed to jette.lautrup.battistini@regionh.dk. To gain access, data requestors will need to sign a data access agreement. Data and explanatory files will be made available at a third party website.

Locations

DK (1)